Follow up Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
2018년 8월 27일 업데이트: Lily Hechtman, McGill University Health Centre/Research Institute of the McGill University Health Centre
Efficacy of Careful Medication and Tailored Case Management Follow up Treatment for Children With Attention Deficit Hyperactivity Disorder
The purpose of the study is to examine how well two types of treatment follow up work compared to one another:
- standard community follow up
- medication monitoring plus tailored case management follow up.
A child's participation will involve 3 months of treatment consisting of medication and psychological, behavioural, and academic interventions tailored to their individual needs.
Following this treatment, the child will be randomly assigned to receive two years of either community follow up or medication monitoring plus tailored case management follow up delivered by the study team. During both types of follow up, at 6 month intervals, the parent and child will be asked to complete interviews with our study personnel and comprehensive assessments pertaining to ADHD symptoms and various other areas of functioning.
Parents will also be asked to obtain information from the child's teacher regarding the child's functioning at 6 month intervals during the school year.
연구 개요
상태
알려지지 않은
연구 유형
중재적
등록 (예상)
326
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Quebec
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Montreal, Quebec, 캐나다, H4H 1R3
- Douglas Mental Health University Institute
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Montreal, Quebec, 캐나다, H4A 3J1
- Montreal Children's Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
6년 (어린이)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- age 6 to 12 years
- DSM-IV ADHD diagnosis by a specialist i.e. child psychiatrist or developmental paediatrician (DSM 5 ADHD criteria do not differ dramatically from DSM IV criteria for children)
- Intelligence Quotient (IQ) > 80 as per the Wechsler Intelligence Scale for Children (WISC-IV)
- Proficiency in English or French
Exclusion Criteria:
- History of Autism Spectrum Disorder (ASD) or psychosis
- Significant brain traumas (encephalitis, head injury requiring hospitalization, etc.)
- Major medical conditions or impairments that would interfere with the ability of the child to complete testing or take psychostimulants, e.g., epilepsy, cardiac abnormalities, or renal abnormalities.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Medication Monitoring & Case Management
All children entered into this study will be prescribed medication for their ADHD symptoms (usually a long-acting stimulant).
Based on the individual needs of the child and family, they could receive the following interventions - Academic and organization skills, social skills training and parent training.
Participants randomized to this group will meet with the study clinicians 4 times a year for medication monitoring and adjustment.
This group will also receive a monthly call from a case manager who will explore the child's academic, social and emotional functioning.
Depending on the needs of the child and family, the case manager may offer 1 to 5 intervention sessions with the child (e.g.
social skills, anger management), the family (e.g.
family counselling), and the school (e.g.
consultation with the teacher).
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This program aims at teaching children organization, time management and stress management skills.
They are also taught academic strategies in reading, writing, and math.
The program consists of six, 90 minute sessions.
The Parent Training Program: The parent training program is designed to increase parental understanding of ADHD; establish attentive, positive interactions, and solve problems collaboratively.
Eight weekly group sessions lasting about 2 hours each will be conducted by trained psychologists, social workers, or clinical nurses.
Homework assignments and detailed summary sheets will be used to promote technique acquisition and generalization.
Social Skills and Anger Management Training: The social skills training program is based on understanding yourself and others, and being able to understand things from the other's perspective.
The program uses direct instruction, modelling, behavioural rehearsal, feedback, and social reinforcement.
The following are covered: joining in, understanding emotions, dealing with anger, using self-control, responding to teasing / bullying, and staying out of fights.
The medication prescribed is usually a long-acting stimulant that is carefully titrated to the child's optimal dose (normally that dose above which further improvement is not seen and side effects are manageable).
Once optimal dose is reached, children are followed at regular once per three month visits for medication monitoring.
In this group the child can be referred for a medication reevaluation and adjustment as many times as is needed.
다른 이름들:
The medication prescribed is usually a long-acting stimulant that is carefully titrated to the child's optimal dose (normally that dose above which further improvement is not seen and side effects are manageable).
Once optimal dose is reached, children are followed by their pediatrician, with a frequency at his/her discretion.
다른 이름들:
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활성 비교기: Community Follow-up Group
All children entered into this study will be prescribed medication for their ADHD symptoms (usually a long-acting stimulant).
Based on the individual needs of the child and family, they could receive the following interventions - Academic and organization skills, social skills training and parent training.
Families randomized to this group will be referred to their pediatricians or family physicians for medication follow-up and their local Community Health Clinic (CLSC) for other psychosocial interventions that may be required and available.
|
This program aims at teaching children organization, time management and stress management skills.
They are also taught academic strategies in reading, writing, and math.
The program consists of six, 90 minute sessions.
The Parent Training Program: The parent training program is designed to increase parental understanding of ADHD; establish attentive, positive interactions, and solve problems collaboratively.
Eight weekly group sessions lasting about 2 hours each will be conducted by trained psychologists, social workers, or clinical nurses.
Homework assignments and detailed summary sheets will be used to promote technique acquisition and generalization.
Social Skills and Anger Management Training: The social skills training program is based on understanding yourself and others, and being able to understand things from the other's perspective.
The program uses direct instruction, modelling, behavioural rehearsal, feedback, and social reinforcement.
The following are covered: joining in, understanding emotions, dealing with anger, using self-control, responding to teasing / bullying, and staying out of fights.
The medication prescribed is usually a long-acting stimulant that is carefully titrated to the child's optimal dose (normally that dose above which further improvement is not seen and side effects are manageable).
Once optimal dose is reached, children are followed at regular once per three month visits for medication monitoring.
In this group the child can be referred for a medication reevaluation and adjustment as many times as is needed.
다른 이름들:
The medication prescribed is usually a long-acting stimulant that is carefully titrated to the child's optimal dose (normally that dose above which further improvement is not seen and side effects are manageable).
Once optimal dose is reached, children are followed by their pediatrician, with a frequency at his/her discretion.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
기간: At baseline - no medication
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At baseline - no medication
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Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
기간: Following 3 months of tailored treatment (including medication)
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Following 3 months of tailored treatment (including medication)
|
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Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
기간: Six months after tailored treatment ends - on medication
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Six months after tailored treatment ends - on medication
|
|
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
기간: Twelve months after tailored treatment has ended - on medication
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Twelve months after tailored treatment has ended - on medication
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|
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
기간: Eighteen months after tailored treatment has ended - on medication
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Eighteen months after tailored treatment has ended - on medication
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Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
기간: Twenty-four months after tailored treatment has ended - on medication
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Twenty-four months after tailored treatment has ended - on medication
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Social skills (measured via Parent and Teacher Social Skills Rating Scale)
기간: At baseline - no medication
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At baseline - no medication
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Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))
기간: At baseline - no medication
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At baseline - no medication
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Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
기간: At baseline - no medication
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At baseline - no medication
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Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
기간: At baseline - no medication
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At baseline - no medication
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Overall functioning (measured via the Clinical Global Impression Scale (CGI))
기간: Assessed at baseline
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Assessed at baseline
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Social skills (measured via Parent and Teacher Social Skills Rating Scale)
기간: Following 3 months of tailored treatment (including medication)
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Following 3 months of tailored treatment (including medication)
|
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|
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
기간: Six months after tailored treatment ends - on medication
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Six months after tailored treatment ends - on medication
|
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Social skills (measured via Parent and Teacher Social Skills Rating Scale)
기간: Twelve months after tailored treatment has ended - on medication
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Twelve months after tailored treatment has ended - on medication
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Social skills (measured via Parent and Teacher Social Skills Rating Scale)
기간: Eighteen months after tailored treatment has ended - on medication
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Eighteen months after tailored treatment has ended - on medication
|
|
|
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
기간: Twenty-four months after tailored treatment has ended - on medication
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Twenty-four months after tailored treatment has ended - on medication
|
|
|
Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))
기간: Twelve month after tailored treatment has ended - on medication
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Twelve month after tailored treatment has ended - on medication
|
|
|
Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))
기간: Twenty-four months after tailored treatment has ended
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Twenty-four months after tailored treatment has ended
|
|
|
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
기간: Following 3 months of tailored treatment (including medication)
|
Following 3 months of tailored treatment (including medication)
|
|
|
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
기간: Six months after tailored treatment ends - on medication
|
Six months after tailored treatment ends - on medication
|
|
|
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
기간: Twelve months after tailored treatment has ended - on medication
|
Twelve months after tailored treatment has ended - on medication
|
|
|
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
기간: Eighteen months after tailored treatment has ended - on medication
|
Eighteen months after tailored treatment has ended - on medication
|
|
|
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
기간: Twenty-four months after tailored treatment has ended - on medication
|
Twenty-four months after tailored treatment has ended - on medication
|
|
|
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
기간: Following 3 months of tailored treatment (including medication)
|
Following 3 months of tailored treatment (including medication)
|
|
|
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
기간: Six months after tailored treatment ends - on medication
|
Six months after tailored treatment ends - on medication
|
|
|
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
기간: Twelve months after tailored treatment has ended - on medication
|
Twelve months after tailored treatment has ended - on medication
|
|
|
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
기간: Eighteen months after tailored treatment has ended - on medication
|
Eighteen months after tailored treatment has ended - on medication
|
|
|
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
기간: Twenty-four months after tailored treatment has ended - on medication
|
Twenty-four months after tailored treatment has ended - on medication
|
|
|
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
기간: Following 3 months of tailored treatment (including medication)
|
Following 3 months of tailored treatment (including medication)
|
|
|
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
기간: Three months after tailored treatment ends - on medication
|
For participants randomized to the medication monitoring and tailored case management follow-up group.
|
Three months after tailored treatment ends - on medication
|
|
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
기간: Six months after tailored treatment ends - on medication
|
For participants randomized to the medication monitoring and tailored case management follow-up group.
|
Six months after tailored treatment ends - on medication
|
|
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
기간: Nine months after tailored treatment ends - on medication
|
For participants randomized to the medication monitoring and tailored case management follow-up group.
|
Nine months after tailored treatment ends - on medication
|
|
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
기간: Twelve months after tailored treatment ends - on medication
|
For participants randomized to the medication monitoring and tailored case management follow-up group.
|
Twelve months after tailored treatment ends - on medication
|
|
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
기간: Fifteen months after tailored treatment ends - on medication
|
For participants randomized to the medication monitoring and tailored case management follow-up group.
|
Fifteen months after tailored treatment ends - on medication
|
|
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
기간: Eighteen months after tailored treatment ends - on medication
|
For participants randomized to the medication monitoring and tailored case management follow-up group.
|
Eighteen months after tailored treatment ends - on medication
|
|
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
기간: Twenty-one months after tailored treatment ends - on medication
|
For participants randomized to the medication monitoring and tailored case management follow-up group.
|
Twenty-one months after tailored treatment ends - on medication
|
|
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
기간: Twenty-four months after tailored treatment ends - on medication
|
For participants randomized to the medication monitoring and tailored case management follow-up group.
|
Twenty-four months after tailored treatment ends - on medication
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Ridha Joober, MD, PhD, Douglas Mental Health University Institute
- 수석 연구원: Natalie Grizenko, MD, FRCPC, Douglas Mental Health University Institute
- 수석 연구원: Lily Hechtman, MD, FRCPC, McGill University Health Centre/Research Institute of the McGill University Health Centre
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2012년 12월 1일
기본 완료 (예상)
2019년 2월 1일
연구 완료 (예상)
2019년 2월 1일
연구 등록 날짜
최초 제출
2014년 5월 14일
QC 기준을 충족하는 최초 제출
2014년 5월 16일
처음 게시됨 (추정)
2014년 5월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 8월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 8월 27일
마지막으로 확인됨
2018년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- MOP 123412
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Academic and Organization skills에 대한 임상 시험
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Queens College, The City University of New York완전한